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GB 24788-2009Limits for the removable surface powder and the water-extractable protein of medical gloves (English PDF)

医用手套表面残余粉末、水抽提蛋白质限量

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Issued by

AQSIQ; SAC

Level / Type

National · Mandatory

Issue date

December 15, 2009

Implementation date

October 1, 2010

Scope

GB 24788-2009 is the English-translated version of 医用手套表面残余粉末、水抽提蛋白质限量.

China's mandatory limits for the two things a medical glove leaves behind on the people who use it and on the patient it touches: the donning powder on its surface and the water soluble protein extractable from the natural rubber latex it is made of.

Both matter clinically rather than cosmetically. The powder carries latex protein into the air of the operating theatre and into the surgical wound, where it has been implicated in adhesion formation and granuloma; the extractable protein is the antigen responsible for the type I latex allergy that ended the careers of a generation of theatre staff.

The standard specifies the limits for the removable surface powder and for the water-extractable protein of medical gloves, together with the corresponding test methods and the marking, and it applies to the gloves used in medical practice, both the examination gloves and the surgical gloves, powdered and powder-free.

The removable surface powder is determined by washing the glove and gravimetrically recovering what comes off, in accordance with GB/T 21869; the water-extractable protein is determined on an aqueous extract of the glove by the modified Lowry method of GB/T 21870, which is the method the international standards use for the same purpose.

The standard also sets how a glove may be described as powder-free, which is a claim with a numerical threshold behind it and not a marketing term. Issued on 15 December 2009 and in force since 1 October 2010.

A new edition, GB 24788-2025, has since been issued and broadens the document into general safety technical requirements for medical gloves.

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Document preview — GB 24788-2009

National Standard of the People's Republic of China

ICS: 11.140
Classification: C 31

Issued by: General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of the PRC

1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking

1 Scope

This standard specifies the limits for the removable surface powder and for the water-extractable protein of medical gloves, together with the corresponding test methods and the marking.

It applies to the gloves used in medical practice, including the examination gloves and the surgical gloves, whether powdered or powder-free.

Why the two limits exist

The donning powder does not stay on the glove. It becomes airborne when the glove is put on and removed, it carries latex protein with it into the air of the operating theatre, and it enters the surgical wound, where it has been implicated in adhesion formation and in granuloma.

The water-extractable protein is the antigen behind the type I latex allergy that developed into an occupational disease among theatre and laboratory staff. Limiting it at the product is the only control that reaches every user, which is why this is a mandatory standard rather than a recommended one.

Requirements and test methods

Clause 4 sets the numerical limits for the removable surface powder and for the water-extractable protein, and sets the threshold below which a glove may be described as powder-free - a claim with a number behind it, not a marketing term.

Clause 5 gives the test methods: the removable surface powder is determined by washing the glove and gravimetrically recovering what comes off, in accordance with GB/T 21869-2008, and the water-extractable protein is determined on an aqueous extract of the glove by the modified Lowry method of GB/T 21870-2008, the same method used internationally for this purpose. Clause 6 sets what the marking must declare.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB 24788-2025|GB/T 21869|GB/T 21870|GB 10213|GB 7543|GB 15979

Editions of GB 24788

Edition	Title	Revision	Status
GB 24788-2025	Medical gloves - Safety technical requirements	current revision	Issued
GB 24788-2009	Limits for the removable surface powder and the water-extractable protein of medical gloves	first issue	In force

This page sells the current edition, GB 24788-2009. Earlier editions are listed for reference only.

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